1.
Effect of ruxolitinib on the oral mucosa of patients with steroid-refractory chronic Graft-versus-Host disease and oral involvement
Kaurinovic, M., Delli, K., Jonk, A. E., Biswana, A., Hazenberg, C. L. E., Choi, G., de Groot, M. R., Morsink, L. M., Vissink, A., Bellido, M.
Clinical oral investigations. 2022
Abstract
BACKGROUND Chronic Graft-versus-Host Disease (cGVHD) can impact quality of life, especially in patients with oral involvement. Half of the patients with cGVHD do not respond to first-line therapy with corticosteroids and calcineurin inhibitors. Ruxolitinib is effective in steroid-refractory (SR)-cGVHD cases, but the long-term effects of ruxolitinib on the oral mucosa are unknown. OBJECTIVE(S): This study aims to assess the effect of ruxolitinib on the oral mucosa of SR-cGVHD patients with oral involvement. MATERIALS AND METHODS An observational longitudinal patient study was conducted in 53 patients with SR-cGVHD and oral involvement who were treated with ruxolitinib. The baseline condition of the oral mucosa was compared to its condition at 4 and 12 weeks after starting ruxolitinib. RESULTS The overall response was 81% (43/53), with a complete response in 53% (28/53) and partial response in 28% (15/53) after 12 weeks (p < 0.001). Men and patients concurrently using immunosuppressive therapy responded better than women (p = 0.005) and patients with ruxolitinib monotherapy (p = 0.02), respectively. At a longer follow-up (median 20 months), oral symptoms were comparable to the 12-week symptoms (p = 0.78), regardless of ruxolitinib use (p = 0.83). CONCLUSION Ruxolitinib treatment of SR-cGVHD patients with oral involvement was associated with a significant response of the oral manifestations at 12 weeks. CLINICAL RELEVANCE The oral mucosa of SR-cGVHD patients is likely to improve after 4 and 12 weeks of ruxolitinib treatment. Symptom severity at baseline does not affect the response of the oral mucosa.
2.
Safety and Side Effects of Using Placenta-Derived Decidual Stromal Cells for Graft-versus-Host Disease and Hemorrhagic Cystitis
Baygan, A., Aronsson-Kurttila, W., Moretti, G., Tibert, B., Dahllof, G., Klingspor, L., Gustafsson, B., Khoein, B., Moll, G., Hausmann, C., et al
Frontiers in Immunology. 2017;8:795
Abstract
Mesenchymal stromal cells (MSCs) are increasingly used in regenerate medicine. Placenta-derived decidual stromal cells (DSCs) are a novel therapy for acute graft-versus-host-disease (GVHD) and hemorrhagic cystitis (HC) after allogeneic hematopoietic stem cell transplantation (HSCT). DSCs are more immunosuppressive than MSCs. We assessed adverse events and safety using DSCs among 44 treated patients and 40 controls. The median dose of infused cells was 1.5 (range 0.9-2.9)x106DSCs/kg. The patients were given 2 (1-5) doses, with a total of 82 infusions. Monitoring ended 3months after the last DSC infusion. Three patients had transient reactions during DSC infusion. Laboratory values, hemorrhages, and transfusions were similar in the two groups. The frequency of leukemic relapse (2/2, DSC/controls) and invasive fungal infections (6/6) were the same in the two groups. Causes of death were those seen in HSCT patients: infections (5/3), respiratory failure (1/1), circulatory failure (3/1), thromboembolism (1/0), multiorgan failure (0/1), and GVHD and others (2/7). One-year survival for the DSC patients with GVHD was 67%, which was significantly better than achieved previously at our center. One-year survival was 90% in the DSC-treated HC group. DSC infusions appear safe. Randomized studies are required to prove efficacy.
3.
Efficacy of palifermin on oral mucositis and acute GVHD after hematopoietic stem cell transplantation (HSCT) in hematology malignancy patients: a meta-analysis of trials
Mozaffari, H. R., Payandeh, M., Ramezani, M., Sadeghi, M., Mahmoudiahmadabadi, M., Sharifi, R.
Contemporary oncology (Poznan, Poland). 2017;21(4):299-305
Abstract
Aim of the study: Herein, this meta-analysis study evaluated the efficacy of palifermin after HSCT on the incidence and severity of OM or aGVHD in hematologic malignancy patients in randomized clinical trials (RCTs). Materials and methods: To compare the efficacy of palifermin on adverse events, OM and aGVHD compared with placebo, we searched databases of PubMed/Medline, Web of Science and Cochrane Library for RCTs based on a number of criteria. Results: There was no difference observed in the incidence of OM and aGVHD between two groups. The subgroup analysis didn't show significant differences in two groups for aGVHD grade 2-4 (odds ratio [OR] = 1.54, 95% confidence interval (CI): 0.70-3.39, p = 0.28), aGVHD grade 3-4 (OR = 0.97, 95% CI: 0.48-1.94, p = 0.92), OM grade 2-4 (OR = 0.76, 95% CI: 0.42-1.38, p = 0.37) and OM grade 3-4 (OR = 0.54, 95% CI: 0.25-1.15, p = 0.11], but erythema as an adverse effect in palifermin group was higher than placebo group (OR = 1.86, 95% CI: 1.10-3.15, p = 0.02]. Conclusions: This meta-analysis of six clinical trials found no statistically significant difference in OM and aGVHD grades in patients receiving 60 mug/kg/day dose of palifermin compared with those receiving a placebo. However, oral mucosal erythema was more prevalent among patients receiving palifermin than patients receiving a placebo.